A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks
• HbA1c value between 7.0 and 10.0%
• Body Mass Index (BMI) 20.0 - 45.0 kg/m2
• Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

Exclusion Criteria:

• Type 1 diabetes mellitus patients
• Serum creatinine > upper limit of normal
• Proteinuria (albumin/creatinine ratio > 300mg/g)
• Dysuria and/or urinary tract infection, genital infection
• Significant renal, hepatic or cardiovascular diseases
• Severe gastrointestinal diseases